161.32—Format of data submission.
(a) Transmittal document.
All data submitted at the same time and for review in support of a single administrative action (e.g., an application for registration, reregistration, experimental use permit, or in response to a requirement for data under the authority of FIFRA sec. 3(c)(2)(B), must be accompanied by a single transmittal document including the following information:
(1)
The identity of the submitter, or the identity of each joint submitter and of the agent for joint submitters;
(3)
The identification of the Agency action in support of which the data are being submitted, such as the registration number or file symbol, petition number, experimental use permit number, or registration standard review; and
(4)
A bibliography of all specific documents included in the submission and covered by the transmittal.
(b) Individual studies.
(1)
All data must be submitted in the form of individual studies. Unless otherwise specified by the Agency, each study should address a single data requirement, and be listed separately in the bibliography.
(ii)
A Statement of Data Confidentiality Claims and, if desired, a Supplemental Statement of Data Confidentiality Claims, in accordance with § 161.33 ;
(iii)
A certification with respect to Good Laboratory Practice standards, if required by § 160.12 of this chapter ;
(iv)
If the original study is not in the English language, a complete and accurate English translation under the same cover; and
(v)
If the study is of a type listed in § 161.34(b), the statement prescribed by paragraph (c) of that section.
(3)
Three identical copies of each study must be submitted. If the study is submitted in conjunction with a pending Special Review or Registration Standard under development, four copies must be submitted. Three copies must be identical and must conform to the requirements of § 161.33 with respect to claims of confidentiality. The fourth copy will be placed in the public docket and must conform to the requirements of § 154.15(c) of this chapter or § 155.30(c) of this chapter with respect to claimed confidential business information.
(4)
All copies must be in black ink on uniform pages of white, 8 1/2 × 11 inch paper. Copies must have high contrast and good resolution for microfilming. Frayed or oversize pages and glued bindings are not acceptable.
(c) Contents of title page.
Each individual study must have a title page bearing the following identifying information:
(1)
The title of the study, including identification of the substance(s) tested and the test name or data requirement addressed;
(4)
If the study was performed in a laboratory, the name and address of the laboratory and any laboratory project numbers or other identifying codes;
(5)
If the study is a commentary on or supplement to another previously submitted study, full identification of the other study with which it should be associated in review; and
(6)
If the study is a reprint of a published document, all relevant facts of publication, such as the journal title, volume, issue, inclusive page numbers, and date of publication.
(d) EPA identification number.
EPA will assign each study an EPA Master Record Identification (MRID) number, and will promptly notify the submitter of the number assigned. This number should be used in all further communications with the Agency about the study.
(e) Reference to previously submitted data.
Data which previously have been submitted need not be resubmitted unless resubmission is specifically requested by the Agency. If an applicant or registrant wishes the Agency to consider such data in the review of an Agency action, he should cite the data by providing: